PROFORE◊

Multi-Layer Compression Bandage System

About PROFORE

PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.1

PROFOREis the gold standard 4 layer compression system which is backed up with extensive clinical evidence and support. A range of products is available to suit patient needs and expert support is provided through study days and education.

PROFORE provides approximately 40mm Hg pressure at the ankle decreasing to 17mm Hg at the knee.2

What is a Leg Ulcer?

A leg ulcer may be defined as a loss of skin below the knee on the leg or foot. Leg ulcers can often be unsightly, painful and slow to heal. Whether they are venous, arterial or of mixed aetiology, nearly 80% of all leg ulcer patients are cared for in the community3, 4

Leg ulcer treatment can be reduced to once a week with compression bandages as multi-layer bandages can be left in place for up to 7 days.

PROFORE Product Range

Key

PROFORE Components

All components of the PROFORE multi-layer bandage system are also available individually.

The median days to healing were 90 days with 4LB compared with 99 days with SSB. There is significant evidence that 4LB heals patients faster than SSB. Patients are 36% more likely to heal with 4LB compared to SSB during a period of treatment.

PROFORE has been shown to achieve complete wound closure in 79% of venous ulcers by 12 weeks and 84% by 24 weeks. 2

First Line Therapy for Venous Leg Ulcers: A Recommended Management Pathway

The International Leg Ulcer Advisory Board (ILUAB) is an international expert panel comprising of some of the most eminent clinicians and researchers in the field of venous leg ulceration. Following an extensive review of the literature available on venous leg ulcers the Leg Ulcer Advisory Board met to design a recommended management pathway for the condition.

Meta-analysis of 5 clinical trials with individual patient data, suggesting a definitive improvement in healing rates with 4LB as opposed to SSB.

The median days to healing were 90 days with 4LB compared with 99 days with SSB. There is significant evidence that 4LB heals patients faster than SSB. Patients are 36% more likely to heal with 4LB compared to SSB during a period of treatment.

This is the first meta-analysis using individual patient data in wound healing. Rigorously analysed and checked data covering 5 randomised clinical trials and 797 patients indicate that 4LB is more effective than SSB in the treatment of venous leg ulcers, with 4LB healing patients faster.

Author

Gannon R

Title

A review of the four layer vs the short stretch bandage system

Reference

Br J Nurs 16(11):S14-8 2007

Summary

A highly analytical and rigorous review of the studies in this area, assessing their strength and possible sources of bias.

It concludes that 4LB is a better system than SSB. Studies that favour SSB have generally been carried out in centres that are not familiar with 4LB and therefore are not applying it properly.

Author

Cullum N, Nelson EA, Fletcher AW, Sheldon TA.

Title

Compression for venous leg ulcers

Reference

Cochrane Database Syst Rev (3): CD000265 2000

Summary

A very important review collecting the results of 22 trials reporting 24 comparisons.

Regarding four-layer compression versus SSB, the review concludes that: Multi-layered high compression was more effective than single-layer. A high compression stocking plus a thrombo stocking is more effective than the SSB system.

Author

Iglesias C, Nelson EA, Cullum NA, Torgerson DJ

Title

VenUS1: a randomized trial of two types of bandage for treating venous leg ulcers.

Reference

Health Technol Assess 8(29):iii 1-105 2004

Summary

A good health economic analysis comparing healing time and rates, and the cost of healing for a four-layer system and a short-stretch bandage system.

387 patients were randomised to either 4 layer bandaging (many different systems) or SSB (many different types). At 12 weeks there was no significant difference in healing between the two systems: 46% vs 37%. At 24 weeks healing rates were significantly different: 68% and 55%. Time to healing was shorter in the 4LB group: 92 days vs 126 days and the SSB system cost over £270 more per patient per year.

Patients were unable to wash the SSB as recommended by manufacturers, which added to the cost. Finally, more patients withdrew from the SSB group. This was a well-powered study and, unlike many of the other comparative studies, bias was reduced by ensuring that bandage applicators received thorough training in both systems.

Author

Carr L, Philips Z, Posnett J.

Title

Comparative cost-effectiveness of four-layer bandaging in the treatment of venous leg ulceration.

Reference

J Wound Care 8(5):243-8 1999

Summary

This study provides excellent cost-effectiveness data for PROFORE and all aspects of treating venous leg ulcers.

Using published healing rates a model was used to calculate the cost per patient of treating venous leg ulcers, over the course of one year comparing PROFORE with the Charing Cross System. Very detailed costs of PROFORE and the original Charing Cross system are provided. The authors conclude that although PROFORE was marginally more expensive, if the better healing rates of PROFORE are taken into account, it is a cheaper system.

The authors also compared a systematic treatment regimen using PROFORE with usual care (specified as normal saline, NA dressing, gauze padding and compression). The PROFORE system was unambiguously more cost effective due to the reduced frequency of dressing changes and the better healing rates and time to heal with PROFORE. Patient outcomes were improved and annual treatment costs were reduced with PROFORE.

In this randomised controlled trial with one year follow up, 233 patients were randomised to four-layer bandaging in a leg ulcer clinic or standard therapy at home. Ulcers healed faster in the four-layer group, with no significant difference in cost. Although this study provides good evidence that four-layer compression therapy in a dedicated clinic with trained bandagers is a cost-effective way of treating leg ulcers, it is flawed in that it is not possible to separate out the effects of the bandaging system from the place of care.

252 patients were enrolled prospectively to receive compression and no other adjuvant techniques. Two forms of compression were used for venous ulcers: Unna's Boot (18%) and PROFORE (69%) and three-layer compression for mixed venous-arterial. Healing rates and costs of care were calculated. Healing rates were 57% at 10 weeks and 75% at 16 weeks. Ultimately 96% of ulcers healed. The authors concluded that compression alone without reconstructive surgery or advanced skin products, produces good healing rates at a modest cost.

A comparison of PROFORE with the original Charing Cross four-layer bandage system.

This was a prospective randomised stratified parallel-group open trial on 233 patients to compare PROFORE with the original 4LB bandaging system. Complete healing at 12 weeks was better with PROFORE, but there was no difference at 24 weeks. The authors concluded that ulcer healing was as good with PROFORE as with the original 4LB system.

A good review of published studies on compression itself and the method of compression.

Four-layer bandaging whether elastic or inelastic (eg SSB) both provide good compression, but four-layer compression is better if the patient is not mobile. The SSB system relies on the resistance of the bandage against the patient's working calf muscle in order to be effective so is less useful if the patient is not mobile. Also, it does not adjust to changes in shape of the leg. But the reviewers conclude that the SSB system probably has more effect than four-layer bandaging on deep veins.

One of the few studies which found statistically significant differences between the two systems.

43 patients with venous leg ulcers were randomised to long or short stretch bandages. Pressures were measured at rest and while walking for up to one year. Long-stretch bandages maintained significantly higher pressure in the upright position, sitting and walking than did SSB after 2 and 24 hours. In contrast to generally held opinion, the SSB did not produce higher peak pressures during working of the calf muscles.

Author

Barlow J

Title

Prescribing for leg ulcers in general practice, part 2.

Reference

J Wound Care 8(8):390-4 1999

Summary

This study provides valuable information as to who makes decisions about product selection in the management of leg ulcers and what factors influence those decisions.

The authors conclude that the majority of decisions are made by practice and district nurses and patient comfort and compliance are the most important factors in their choice. Nurses do not use the best available evidence because of lack of time to search literature and lack of resources.

A study which provides important information about factors affecting compliance with compression therapy.

A retrospective review of data on 113 patients. Mean time to healing was 5.3 months and complete ulcer healing overall occurred in 97% of compliant patients, but in only 55% of those who were non-compliant with therapy. Total ulcer recurrence was 16% in compliant patients and 100% in non-compliant.

Instructions for Use

Only apply PROFORE following training in its application and with knowledge of the use of compression therapy in patients with compromised arterial circulation.

PROFORE is for single use only.

A Step by Step Application Demonstration for the 18-25cm Kit

BEFORE APPLYING THE FIRST BANDAGE It is important to check the following:

Assess the patient thoroughly to ensure that sufficient arterial supply exists to apply compression therapy. The use of Doppler ultrasound is recommended. Ankle : Brachial pressure index (ABPI) should be greater than 0.8.

Measure the ankle circumference to confirm that it is greater than 18cm (padded).

Check if the patient's ankle circumference has changed due to a reduction in oedema. Always re-measure after the initial treatment period and check the bandage selection guide for the correct kit for the size of leg.

Assess the patient's limb for bony prominences or calf fibrosis. Ensure that these are well protected using the PROFORE #1 padding to distribute pressure evenly.

Apply PROFORE in the Following Sequence:

Step 1: PROFORE WCL Sterile Wound Contact LayerDo not use if pouch is opened or damaged. Remove from the pack with sterile forceps and apply to the wound. Hold in place until covered by PROFORE #1.

Step 2: PROFORE #1 Absorbent Padding BandageBandage the foot using an ankle lock. Apply from the ankle to the knee using a simple spiral technique and 50% overlap. Do not apply tension.

Step 3: PROFORE #2 Light Conformable BandageBandage the foot using an ankle lock. Apply from the ankle to the knee over PROFORE #1, using a simple spiral technique, apply at mid stretch and 50% overlap. Use tape to secure.

Step 4: PROFORE #3 Light Compression BandageBandage the foot using an ankle lock. Apply from the ankle to the knee, using a figure of eight technique at 50% extension. Use the central line as guidance. Use tape to secure.

Step 5: PROFORE #4 Flexible Cohesive BandageBandage the foot using an ankle lock. Apply from ankle to knee using a spiral technique with 50% extension and 50% overlap. Press lightly on the bandage to ensure that the bandage adheres to itself.

FAQs

Frequently Asked Questions about PROFORE

Q: What is PROFORE?

A: PROFORE is a multi-layer compression bandaging system consisting of 5 components: a sterile wound contact layer; a padding bandage; a light conformable bandage; a light compression bandage and a flexible cohesive bandage.

Q: How much compression does PROFORE deliver?

A: Current understanding is that optimum compression therapy is achieved with a sub-bandage pressure of 40mm Hg at the ankle. This has become the benchmark pressure for compression bandages).

PROFORE is designed to apply sustained graduated pressure of 40mmHg to the ankle area decreasing to 17mm Hg at the knee. It is supplied in 4 compression strengths to cover all sizes of ankle.

Q: How does compression heal a leg ulcer?

A: Compression helps to reverse the venous insufficiency in the leg, healing any damage and helping to direct the flow of blood back towards the heart.

Q: What wound contact layers can be used under PROFORE?

A:PROFORE has been developed to work with PROFORE WCL (TRICOTEX*) a low adherent wound contact layer consisting of a single layer of knitted, bright viscose.

Q: Can PROFORE be used on patients with a history of DVT?

A: It is unlikely that compression would exert any effects on the deep veins and so compression is not contra-indicated. Elastic Compression is considered to be an indispensable complement to anti-coagulant treatment for DVT. Venous insufficiency is a risk factor for DVT, compression therapy improves this condition

Q: Does PROFORE contain latex?

A: Yes, the standard kit contains latex, however there are latex free formulation kits available for all ankle circumferences and compression variants which are specially formulated with no latex containing ingredients.

A: No, PROFORE Latex Free formulation is free from potential known allergens such as colophony, thiuram and carbamate. However, to be 100% sure, patch testing is recommended prior to use.

Q: What is the shelf life for PROFORE?

A: The shelf life of PROFORE is 3 years.

Q: How is PROFORE WCL sterilised?

A: PROFORE WCL (TRICOTEX) is sterilised using gamma radiation.

Q: What is the wear time of PROFORE?

A: PROFORE can be worn for up to 7 days, depending on the level of exudate. At the start of treatment it may be necessary to change the bandage twice a week as the oedema reduces.

PROFORE Lite delivers 23mm Hg pressure and can be worn on the leg for up to 7 days.

Q: When should I use PROFORE?

A: PROFORE should be used on venous leg ulcers and associated conditions.

Q: Why is PROFORE available in 4 kit sizes?

A: PROFORE has been designed to provide the correct level of compression for all ankle circumferences. Most conventional bandages are only available in one size. On larger ankle circumferences the pressure delivered by these bandages will be less than the optimum 40mm Hg.

PROFORE is available in 4 sizes to ensure that every ankle circumference receives the correct level of compression.

Q: How do I write a PROFORE prescription and what are the components of each kit?

A: This technique ensures the sub-layers are held in place and ensures the correct pressure level is applied to the limb.

Q: Why aren't all bandages applied in a figure of 8 technique?

A: By crossing the bandages on the tibia, localised pressure on the bone is increased which may cause pressure damage.

Q: Should you measure the ankle before or after padding with PROFORE #1?

A: If the leg is very thin, you should measure before and after padding to ensure that the correct kit is selected. For example, if an ankle measures 15cm before padding, but 18cm after padding, then the 18-25cm kit should be applied. The narrower the leg the higher the level of pressure is delivered.

Q: Why is the bandage slipping between applications?

A: Check the consistency of bandaging to ensure it isn't under stretched at the top of the limb. Ensure the padding layer is used to achieve a graduated leg shape as a basis for bandage application.

Q: How do patients tolerate PROFORE?

A: The rapid improvement of the venous return delivered by sustained graduated pressure relieves the internal tension in the leg and gives a lightening feeling. As a result patient tolerance is very high.